PedvaxHIB

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Pedvax HIB

INDICATIONS

Liquid PedvaxHIB is indicated for routine vaccination against invasive disease
caused by Haemophilus influenzae type b in infants and children 2 to
71 months of age.

Liquid PedvaxHIB will not protect against disease caused by Haemophilus
influenzae other than type b or against other microorganisms that cause
invasive disease such as meningitis or sepsis. As with any vaccine, vaccination
with Liquid PedvaxHIB may not result in a protective antibody response in all
individuals given the vaccine.

BECAUSE OF THE POTENTIAL FOR IMMUNE TOLERANCE, Liquid PedvaxHIB IS NOT RECOMMENDED
FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE. (See PRECAUTIONS.)

Revaccination

Infants completing the primary two-dose regimen before 12 months of age should
receive a booster dose (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Liquid PedvaxHIB

FOR INTRAMUSCULAR ADMINISTRATION

DO NOT INJECT INTRAVENOUSLY

If there is an interruption or delay between doses in the primary series, there
is no need to repeat the series, but dosing should be continued at the next
clinic visit. (See CONTRAINDICATIONSandPRECAUTIONS.)

2 to 14 Months of Age

Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine ideally
beginning at 2 months of age followed by a 0.5 mL dose 2 months later (or as
soon as possible thereafter). When the primary two-dose regimen is completed
before 12 months of age, a booster dose is required (see below and TABLE 6).
Infants born prematurely, regardless of birth weight, should be vaccinated at
the same chronological age and according to the same schedule and precautions
as full-term infants and children.46

15 Months of Age and Older

Children 15 months of age and older previously unvaccinated against Hib disease
should receive a single 0.5 mL dose of vaccine.

Booster Dose

In infants completing the primary two-dose regimen before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months of age, but not earlier than 2 months after the second dose.

Vaccination regimens for Liquid PedvaxHIB by age group are outlined in TABLE 6.

TABLE 6
Vaccination Regimens for Liquid PedvaxHIB By Age Groups

Age (Months) at First Dose

Primary

Age (Months) at Booster Dose

2-10

2 doses, 2 mo. apart

12-15

11-14

2 doses, 2 mo. apart

-

15-71

1 dose

-

Interchangeability

PedvaxHIB may be interchanged with other licensed Haemophilus b Conjugate Vaccines
for the primary and booster doses.52 (See CLINICAL PHARMACOLOGY.)

The type, frequency and severity of adverse experiences observed in these studies
with PedvaxHIB were similar to those seen with the other vaccines when given
alone. (See CLINICAL PHARMACOLOGY.)

In addition, a PRP-OMPC-containing product, COMVAX [Haemophilus b Conjugate
(Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was
given concomitantly with a booster dose of DTaP [diphtheria, tetanus, acellular
pertussis] at approximately 15 months of age, using separate sites and syringes
for injectable vaccines. No impairment of immune response to these individually
tested vaccine antigens was demonstrated. COMVAX has also been administered
concomitantly with the primary series of DTaP to a limited number of infants.
PRP antibody responses are satisfactory for COMVAX, but immune responses are
currently unavailable for DTaP (see Manufacturer's Product Circular for COMVAX).
No serious vaccine-related adverse events were reported.33

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.

Inject 0.5 mL intramuscularly, preferably into the anterolateral thigh or the outer aspect of the upper arm. The buttocks should not be used for active vaccination of infants and children, because of the potential risk of injury to the sciatic nerve.